{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "130181",
      "product_res_number": "Z-0102-2015",
      "event_date_initiated": "2014-09-15",
      "event_date_posted": "2014-10-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-12-28",
      "res_event_number": "69292",
      "product_code": "LOM",
      "pma_numbers": [
        "P040004"
      ],
      "product_description": "Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use\nCatalog Number: 07566733 \nSiemens Material Number: 10309508\n\nThe ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.",
      "code_info": "Lot Number: 100064  Exp.Date:February 10, 2015",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "Same\n508-668-5000",
      "reason_for_recall": "Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director.\nEach customer will be required to return a completed confirmation fax-back to Siemens.",
      "product_quantity": "5434 (200 tests)",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and  Yemen.",
      "openfda": {
        "k_number": [
          "K260770"
        ],
        "pma_number": [
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          "P100032",
          "P060009",
          "P110029",
          "P790025",
          "P850044",
          "P030040",
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          "P830014",
          "P030026",
          "P100039",
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          "P010054",
          "P000044",
          "P060007",
          "P050049",
          "P010053",
          "P110022",
          "P190034",
          "P160019",
          "P190005",
          "P990042",
          "P060034",
          "P060035",
          "P780016",
          "P000014",
          "P110031",
          "P990044",
          "P060031",
          "P180039",
          "P990012",
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          "P030024",
          "P050048",
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          "P040004",
          "P990041",
          "P130015",
          "P180049",
          "P100001",
          "P010052",
          "P030029"
        ],
        "registration_number": [
          "2032682",
          "3012963943",
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          "3011989923",
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          "3002806944",
          "2432235",
          "3008576040",
          "3008344661",
          "3000308930",
          "3032705"
        ],
        "fei_number": [
          "3002808328",
          "3012963943",
          "3005670738",
          "3003952975",
          "3002807272",
          "3011989923",
          "3002809144",
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          "1219913",
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          "2432235",
          "3002808212",
          "3008576040",
          "3008344661",
          "3000308930",
          "3002701146"
        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}